Drugs / Voxelotor

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Oxbryta 2022-02-14 europa.eu
Label expansion US (FDA) OXBRYTA 2021-12-17 fda.gov
Approved US (FDA) OXBRYTA 2019-11-25 fda.gov

Trials 27 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 18 trials
Phase 1 NCT05981365 Apr → Oct 2023 sickle cell disease Pfizer Completed No outcome recorded
Phase 1 NCT03114540 Mar 2017 → Feb 2018 Pfizer Completed No outcome recorded
Phase 1 NCT03051711 Dec 2016 → Dec 2017 Global Blood Therapeutics Terminated No outcome recorded
Phase 1 NCT03161015 Nov 2016 → May 2017 impaired renal function disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02567682 Sep 2015 → May 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02567695 Sep 2015 → Jun 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02497924 Jun 2015 → Jul 2016 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1 NCT02285088 Dec 2014 → Mar 2017 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT04335721 Mar 2021 → Oct 2024 sickle cell disease University of Illinois at Chicago Terminated No outcome recorded
Phase 29 trials
Phase 2 NCT06023199 Oct 2023 → Sep 2025 overdue sickle cell disease Inova Health Care Services Active not recruiting No outcome recorded
Phase 2 NCT05199766 Mar 2023 → Mar 2024 sickle cell disease Assistance Publique - Hôpitaux de Paris Unknown No outcome recorded
Phase 2 NCT05289570 May 2022 → Jun 2023 acute lung injury Duke University Terminated No outcome recorded
Phase 2 NCT05018728 Mar 2022 → Oct 2024 sickle cell disease Emory University Terminated No outcome recorded
Phase 2 NCT04247594 Jan 2020 → Jun 2021 sickle cell disease Pfizer Terminated No outcome recorded
Phase 2 NCT02989168 Nov 2016 → Oct 2017 idiopathic pulmonary fibrosis, polycythemia due to hypoxia Global Blood Therapeutics Terminated No outcome recorded
Phase 2 NCT03041909 Aug 2016 → Jun 2017 sickle cell disease Global Blood Therapeutics Completed No outcome recorded
Phase 2 NCT02850406 Jul 2016 → Oct 2023 sickle cell disease Pfizer Terminated No outcome recorded
Phase 2 NCT02846324 Jun 2016 → Sep 2017 idiopathic pulmonary fibrosis, polycythemia due to hypoxia Global Blood Therapeutics Completed No outcome recorded
Phase 35 trials
Phase 3 NCT05228834 Jun → Sep 2022 sickle cell disease Pfizer Terminated No outcome recorded
Phase 3 NCT05561140 May 2022 → Jun 2024 sickle cell disease, ulcer of lower limbs Pfizer Terminated No outcome recorded
Phase 3 NCT04218084 Nov 2020 → Jan 2024 sickle cell disease Pfizer Terminated No outcome recorded
Phase 3 NCT04188509 Nov 2019 → Nov 2024 sickle cell disease Pfizer Terminated No outcome recorded
Phase 3 NCT03573882 Jun 2018 → Nov 2024 sickle cell disease Pfizer Terminated No outcome recorded
Phase 43 trials
Phase 4 NCT05228821 Aug 2023 sickle cell disease Pfizer Withdrawn No outcome recorded
Phase 4 NCT04400487 Dec 2020 → Sep 2022 sickle cell disease Pfizer Completed No outcome recorded
Phase 4 NCT04581356 Sep 2020 → Oct 2021 sickle cell disease Elizabeth Yang, MD, PhD Completed No outcome recorded
Phase not stated1 trial
NCT04724421 sickle cell disease Pfizer No longer available No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT03036813 Comparator Dec 2016 → Oct 2019 sickle cell disease Pfizer Completed No outcome recorded
Phase not stated1 trial
NCT03943615 Background sickle cell disease Pfizer No longer available No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2024-09-25 Pfizer Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets pfizer.com

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 30 sources stand behind the page.

FieldValueCited text
Known as Voxelotor Voxelotor (GBT440) is a first-in-class oral therapy specifically developed to treat SCD” PMID 30655275 Jan 2019
19

NCT04400487

NCT04218084

NCT04335721

NCT05018728

NCT02850406

NCT03573882

NCT04188509

NCT03036813

NCT05289570

NCT03943615

NCT05199766

NCT04724421

NCT04247594

NCT06023199

NCT04581356

NCT05228821

NCT05561140

NCT05981365

NCT05228834

Known as GBT440 “Investigator hypothesis is that the treatment by Voxelotor (GBT440) will improve intra vascular hemolysis and will increase the total mass of hemoglobin with beneficial effects...” NCT05199766
9

“Voxelotor (GBT440) is a first-in-class oral therapy specifically developed to treat SCD” PMID 30655275 Jan 2019

NCT03161015

NCT02989168

NCT02567682

NCT02567695

NCT03114540

NCT02846324

NCT02497924

NCT03051711

Known as GTX-011 ChEMBL registry synonym — accepted as the source's own label CHEMBL4101807
Known as Oxbryta ChEMBL registry synonym — accepted as the source's own label CHEMBL4101807
Action Inhibit “voxelotor-a first-in-class HbS polymerization inhibitor” PMID 35451176 Apr 2022
Modality Small molecule “synthetic small molecule supplied as 500 mg tablets” NCT04247594
Route Oral “GBT440 capsules followed by single dose of \[C14\] GBT440 oral suspension” NCT02497924